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Summary of Contents for IEM Tel-O-Graph BT plus
- Page 1 ® Tel-O-Graph BT plus Operating manual...
- Page 2 52222 Stolberg Germany Telephone: +49 2402 9500-0 Fax: +49 2402 9500-11 E-mail: info@iem.de Website: www.iem.de The content of this operating manual must not be reproduced or published without the written approval of IEM GmbH. © IEM GmbH 2018. All rights reserved.
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Page 3: Table Of Contents
Table of contents Table of contents Measuring blood pressure and pulse ..22 Before measuring ........... 22 Table of contents ............3 Putting the blood pressure cuff on ....22 Introduction ............4 Correct posture ..........25 Clinical validation ..........5 Measuring ............ -
Page 4: Introduction
Introduction Introduction If you have any questions about our services or products, feel free to contact us. ® Thank you for choosing the Tel-O-Graph BT plus upper-arm blood pressure monitor. Read this operating manual carefully before use and keep it in a suitable place so that the information is available when required. -
Page 5: Clinical Validation
(Arm circumference:20-24 cm (7.9-9,5 in)) and bears the CE mark. ▪ Blood pressure cuff "L" ® IEM GmbH hereby declares that the Tel-O-Graph (Arm circumference: 32-38 cm (12.6-15.0 in)) plus corresponds to the 2014/53/EU (RED) guideline. ▪ Blood pressure cuff "XL"... -
Page 6: Instructions For Use
Instructions for use Improper use Instructions for use The blood pressure monitor must not be used for Intended use newborns, during surgery, in the vicinity of MRI ® The Tel-O-Graph BT plus is intended for the home scanners or other strong magnetic fields, or for clinical measurement of blood pressure and pulse on the upper monitoring of patients and during transport of patients. -
Page 7: Essential Performance
Instructions for use Essential Performance the cuff. The cuff is not automatically pressurised, to do so, the device must be initiated manually. The essential performance features are defined as blood pressure measurement with: ▪ Error tolerances of the pressure gauge and measurement results within the required limits according to IEC 80601-2-30. -
Page 8: Safety
Safety Safety ATTENTION This section explains all the safety information for the Short description of the danger device. This warning symbol, in connection with the signal Read this section carefully before using the blood word ATTENTION, indicates possible material pressure monitor. damage. -
Page 9: Important Patient Information
Safety Important patient information WARNING WARNING Danger of tissue bleeding or haematoma. ▪ When using the blood pressure monitor, make Danger as a result of self-diagnosis sure it does not impede the blood circulation in ▪ Do not undertake any changes to your treatment your arm. - Page 10 Safety WARNING WARNING Danger of injury as a result of using unapproved Danger of a temporary loss of function of a accessories present electrical medical device as a result of putting on or pumping up a cuff if you are ▪...
- Page 11 Safety WARNING WARNING Danger of strangulation by the cuff hose Danger of blood flow interruptions as a result of steady cuff pressure or too frequent measuring ▪ Persons (including children) who are unable to use the blood pressure monitor safely due to ▪...
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Page 12: Important Device Instructions
Safety Important device instructions ▪ Measurement can be interrupted at any stage by pressing the button. This deflates the cuff ATTENTION and the cuff can be removed. Equipment failure ▪ The device must not be used in the vicinity of magnetic resonance imaging apparatus or in the direct proximity of another electrical medical monitor. - Page 13 Safety electromagnetic immunity. should ATTENTION therefore only use genuine IEM accessories. ▪ The cuff and the hose are made of a material Batteries that does not conduct electricity. They thus ▪ Remove the batteries from the battery protect the device against the effects of compartment when they no longer have any discharging a defibrillator.
- Page 14 Safety ATTENTION ATTENTION Electric fields Fluid damage to the blood pressure monitor ▪ ▪ Measurements may be faulty if the device is Liquid must not penetrate the device. If you operated in the vicinity of strong electrical believe that liquid has penetrated the device fields.
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Page 15: Description Of Device
Description of device Description of device Blood pressure monitor Fig. 1: Blood pressure monitor Display Battery cover Infrared interface (for service) Air hose socket button... -
Page 16: Blood Pressure Cuff
Description of device Blood pressure cuff Fig. 2: Blood pressure cuff Blood pressure cuff Air hose Air hose connection... -
Page 17: Display
Description of device Display Fig. 3: Display When this appears: Battery empty Number of pulse beats per minutes Display of systolic (upper) value Pulse detected Data transfer Number of measurement values ® Bluetooth Display of diastolic (lower) value Infrared communication... -
Page 18: Ambient Conditions
Description of device Ambient conditions ATTENTION Extreme temperatures, humidity or air pressure can influence measurement accuracy. Please follow the operating instructions. ▪ Never store the blood pressure monitor outside a temperature range of -25 °C to +70 °C. ▪ Never use the blood pressure monitor outside a temperature range of +5 °C to +40 °C. ▪... -
Page 19: Preparing The Measurement
Preparing the measurement Preparing the measurement Keep the packaging so that it can be safely packaged at a later date. Unpacking Inserting the batteries Note All parts included in delivery package have been properly packed and checked for completeness functionality. Should product incomplete, damaged or defect, please inform... - Page 20 Preparing the measurement Note WARNING ▪ Insert the batteries while holding the blood Make sure that all segments are displayed by the pressure monitor in your hand. screen. Inform your healthcare provider if the ▪ Take care not to activate the button on the display is damaged.
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Page 21: Switching The Blood Pressure Monitor On/Off
Preparing the measurement Switching the blood pressure monitor on/off Switching on Fig. 6: Start screen Press the button. The display shows the start screen (Fig. 6). Switching off blood pressure monitor switches automatically after about 5 minutes. -
Page 22: Measuring Blood Pressure And Pulse
Measuring blood pressure and pulse Measuring blood pressure and pulse Putting the blood pressure cuff on Before measuring WARNING ▪ Choose the right cuff size. The blood pressure cuff Risk of injury due to incorrectly connected air size is printed on the cuff. hose! ▪... - Page 23 Measuring blood pressure and pulse Insert the air hose connection into the air hose WARNING socket on the left side of the blood pressure monitor and place the blood pressure monitor on Danger of injury as a result of allergic reactions the table (see fig.
- Page 24 Measuring blood pressure and pulse Note The blood pressure cuff must be directly against your skin. Insert your left arm into the blood pressure cuff. Note Blood pressure cuffs are supplied preassembled. If the cuff is not preassembled, please assemble as follows: ▪...
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Page 25: Correct Posture
Measuring blood pressure and pulse Once the blood pressure cuff is positioned Correct posture correctly, fasten the end with the Velcro. After positioning the blood pressure cuff, assume the correct posture to take the measurements (Fig. 9). Note Place the blood pressure cuff so that there is enough room to insert your index and middle fingers between the skin and the material of the blood pressure cuff. -
Page 26: Measuring
Measuring blood pressure and pulse Relax your arm and turn the palm of your hand Measuring to face upwards. WARNING Place your feet flat on the floor and leave your legs uncrossed. Risk of injuries during measurement! ▪ Do not place the air hose around your neck. Note ▪... -
Page 27: Stopping The Measurement
Measuring blood pressure and pulse ♥ Remove the blood pressure cuff. a pulse, the icon appears. The reading is taken as the air is let out. The blood pressure monitor WARNING confirms the end of the measuring with a short acoustic signal. -
Page 28: Transferring Readings Via Bluetooth
Transferring readings via Bluetooth® ® Active pairing (Bluetooth modem) Transferring readings via Bluetooth If the blood pressure monitor is configured to transfer Note ® readings via Bluetooth , readings will be sent to the database automatically. Pairing requires some basic familiarity with Bluetooth. -
Page 29: Passive Pairing (Tablet, Smartphone)
Transferring readings via Bluetooth® Press the button. display. The data transfer device will be added to the device list automatically. The start screen will be displayed (see fig. 6). Press and hold the button for at least 3 seconds. Note The individual menu options will be displayed. -
Page 30: Memory
Memory Memory ATTENTION Saving readings Data loss To avoid data loss, contact your healthcare provider before or when the display shows 15 measurements. The number of readings is shown on the display (Fig. 10). Fig. 10: Number of readings Note The blood pressure monitor can save 15 blood pressure Previously transmitted data is retained in the readings and 15 pulse rate readings. -
Page 31: Deleting Readings From The Blood Pressure Monitor
Memory Deleting readings from the blood pressure Note monitor Every 3 seconds, the display will automatically To clear the memory on your blood pressure monitor, display the next menu option. The display order proceed as follows: Infrared transmission (IR) ... - Page 32 Memory Press and hold the button for more than 3 seconds. The acoustic signal sounds 3 times and the display shows [M00] (see Fig. 11/C). The measurements are deleted. The device returns to standby mode displays start screen (see Fig. 6).
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Page 33: Cleaning And Disinfection
Cleaning and disinfection Cleaning and disinfection Note WARNING Always observe the manufacturer's instructions on the disinfection and cleaning of these ▪ When putting the blood pressure monitor products. there must longer disinfectants on the blood pressure cuff! ▪ There are patients who have intolerances Cleaning (e.g. - Page 34 Cleaning and disinfection ® Cleaning the Tel-O-Graph BT plus: ATTENTION To clean the blood pressure monitor, use a damp cotton wool pad with a mild laundry detergent. Do not ▪ To clean the bladder and hose, use a mild use any other cleaning materials. fabric softener-free laundry detergent and lukewarm water.
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Page 35: Disinfection
The cuff sleeve size is shown on the outside of the cuff. Disinfection Ask your doctor if and when the cuff needs to be disinfected for hygienic reasons. IEM GmbH has tested the following means for the disinfection: ▪ Isopropanol (70%) ▪... -
Page 36: Maintenance
The metrological check comes at an additional cost and can be carried out in Germany by either IEM GmbH, a competent authority or by authorised maintenance services corresponding to the "Medizinprodukte- Betreiber-Verordnung"... -
Page 37: Disposal
Disposal Disposal Batteries Batteries must not be disposed of with domestic waste. Blood pressure monitor As a consumer you are legally bound to return used batteries. You can return your old batteries to official collection points within your community or everywhere batteries of that type are sold. -
Page 38: Error Messages
Error messages Error messages 12.1 Blood pressure measurement errors The blood pressure monitor indicates blood pressure measurement errors and communication errors by emitting 12 short acoustic signals. Error Cause Remedy description Arm moved during ➔ Keep your arm still during the measurement ( Chapter 6.3). - Page 39 Error messages Error Cause Remedy description IR communication error If this error message is displayed continuously (or repeatedly), Err 4 contact your healthcare provider or the manufacturer. Power pack or battery ➔ Change the batteries ( Chapter 5.2). voltage too low. Err 5 Battery contacts are Clean the battery contacts with a cotton cloth and a little alcohol.
- Page 40 Error messages Error Cause Remedy description Residual pressure in the Err 9 Wait until the blood pressure cuff has deflated completely. blood pressure cuff If this error occurs repeatedly, send the blood pressure monitor to Internal error your healthcare provider or directly to the manufacturer for Err 10 checking.
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Page 41: Communication Error
Error messages 12.2 Communication error Error Cause Remedy description ➔ Error during pairing Repeat the pairing process ( Section 7.2). Cod 1 The data transfer device Switch the device on. is switched off ® No Bluetooth Check that the data transfer device is switched on. If this error Cod 2 connection occurs repeatedly, contact your healthcare provider. -
Page 42: Technical Data And Symbols
Technical data and symbols Technical data and symbols Technical data The blood pressure monitor complies with the EMC directives. The blood pressure cuff and air hose are made of a non-conductive material. This makes the device defibrillator- safe. Specification Value Unit Measuring method Oscillometric... - Page 43 Technical data and symbols Specification Value Unit Material (cuff) Polyester Operating temperature +5 to +40 °C Ambient pressure 700 to 1060 Transport temperature -25 to +70 °C Storage temperature -25 to +70 °C Air humidity, not condensing (operation, 15 to 93 transport and storage) Battery capacity c.
- Page 44 Technical data and symbols Symbols Symbol Meaning 4 x LR6 or HR6, AA with 1.5 V Manufacturer Date of manufacture YYYY-MM-DD Designation of the FCC radio authorisation CE 0044: Labelling of a medical device in accordance with directive 93/42/EEC It may not be possible to use the device everywhere in Europe. Protect from rain and moisture Comply with the operating manual...
- Page 45 Technical data and symbols Symbol Meaning The symbol on the product or packaging means that this product should not be treated as normal domestic waste, but should be taken to a recycling point for electric and electronic devices. You can find out more about this from your local authority, the communal disposal companies or the shop in which you bought the product.
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Page 46: Warranty And Repairs
IEM GmbH does not grant any warranty on the batteries ▪ Faults due to material or production defects shall be provided. -
Page 47: Manufacturer's Emc Guidelines
Manufacturer’s EMC guidelines Manufacturer’s EMC guidelines Electromagnetic interference emissions ® The Tel-O-Graph BT plus is intended to be operated in the electromagnetic environment specified below. Only use ® the Tel-O-Graph BT plus in such an environment. Measurement of – interference Compliance Electromagnetic environment guidelines... - Page 48 Manufacturer’s EMC guidelines Electromagnetic immunity ® The Tel-O-Graph BT plus is intended to be operated in the electromagnetic environment specified below. Only use ® the Tel-O-Graph BT plus in such an environment. – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level...
- Page 49 Manufacturer’s EMC guidelines – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level guidelines IEC 61000-4-4 Not applicable IEC 61000-4-5 Not applicable IEC 61000-4-6 Not applicable Magnetic field at supply Magnet fields at mains frequency should frequency (50/60 Hz) in 30 A/m 30 A/m match the typical values found in...
- Page 50 ® The Tel-O-Graph BT plus has been tested with the following frequencies: Measurement of interference IEC 60601-1 test level Compliance level emissions RF interference emissions 380 - 390 MHz 380 - 390 MHz according to 27 V/m; PM 50%; 18 Hz 27 V/m;...
- Page 51 Rev. A – 18.12.2018...
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